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Comparing treatments for rheumatoid arthritis in patients not responding to TNFi biologics

A Real-World Comparative Effectiveness Trial of Treatment Strategies in Patients With Rheumatoid Arthritis: The RA-PRO Pragmatic Trial (RA-PROPR)

Phase 3 Interventional University of Alabama at Birmingham · NCT04692493

This study is testing whether switching to a different type of medication can help people with rheumatoid arthritis who haven't improved with their current treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment924 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Alabama at Birmingham Academic / other
Drugs / interventionsmethotrexate, prednisone, rituximab, tocilizumab, sarilumab, tofacitinib, baricitinib, upadacitinib
Locations49 sites (Auburn, Alabama and 48 other locations)
Trial IDNCT04692493 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of switching to either a non-TNFi biologic or a targeted synthetic DMARD (tsDMARD) in patients with active rheumatoid arthritis who have not responded adequately to TNFi biologics. The study will generate comparative effectiveness research (CER) data focusing on patient-reported outcomes (PROs) to inform treatment decisions. By addressing a critical knowledge gap regarding the differences in outcomes between these treatment options, the trial seeks to provide evidence-based guidance for clinicians and patients. Participants will be randomized to receive one of the two treatment strategies, with careful monitoring of their health status and treatment responses.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with active, disabling rheumatoid arthritis who have been on TNFi biologics for at least three months without adequate response.

Not a fit: Patients who have not been treated with TNFi biologics or those with rheumatoid arthritis that is well-controlled may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide clearer guidance on the most effective treatment options for patients with rheumatoid arthritis who do not respond to TNFi biologics.

How similar studies have performed: Other studies have indicated the need for more evidence in this area, making this approach both novel and necessary.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patients with active, disabling RA (CDAI ≥10 and HAQ ≥0.5) despite the use/experience of a TNFi-biologic OR discontinued the medication(s) due to intolerability or toxicity irrespective of treatment duration prior to the first dose of study drug ;
2. If receiving glucocorticoids (≤10 mg/day of prednisone of equivalent) or NSAIDs, on stable doses for ≥2 weeks prior to randomization; and
3. Insurance plan or patient assistance program allows access to at least 1 drug in each of the two treatment strategies, TNFi-biologic vs. tsDMARD.(TNFi-biologic and tsDMARD) will be obtained through insurance plan or a patient assistance program/plan.

Participants will be allowed to continue their conventional synthetic DMARD (csDMARD) therapy if they had been using it for ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, and leflunomide

Exclusion Criteria:

1. Prior treatment with more than three biologics, defined as TNFi-biologic or non-TNFi biologic
2. Prior treatment with targeted synthetic DMARD
3. Concomitant use of leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2-months before randomization;
4. History of sensitivity to all 4 non-TNF-biologic or a targeted synthetic DMARD;
5. Glucocorticoid injection (intravenous, intramuscular, or intraarticular) within 1 month of study entry;
6. Live vaccine within 90 days of study entry;
7. Acute or chronic infections with parenteral antibiotics or hospitalization (including tuberculosis, bacterial sepsis; invasive fungal infections (such as histoplasmosis)) within 1 month or oral antibiotics within 2 weeks of study entry;
8. History of HIV or any opportunistic infection;
9. New York Heart Association Class III or IV heart failure;
10. Latent TB for which anti-tubercular treatment has not been started;
11. Untreated Hepatitis B or C infection;
12. History of deep venous thrombosis or pulmonary embolism; or
13. Pregnant or nursing women; or
14. History of herpes zoster or shingles in the previous 12 months and not subsequently vaccinated with herpes zoster vaccine.

Where this trial is running

Auburn, Alabama and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Rheumatoid Arthritis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.